Tanatril達爽

Tanatril Adverse Reactions

imidapril

Manufacturer:

Mitsubishi Tanabe Pharma

Distributor:

Primal
Full Prescribing Info
Adverse Reactions
Adverse reactions to Tanatril were reported in 442 (6.6%) of 6741 patients treated. The most frequently observed adverse reactions were cough 4.5%, dizziness 0.2%, hypotension 0.2%, headache 0.2%, pharynx discomfort 0.2%, rash 0.1%, etc. (Data collected from the time of approval up to November 1996.)
Abnormal laboratory findings suspected to be drug-related were reported in 47 patients (5.6%) of 832 patients treated. Frequently reported abnormal findings were increased SGOT (1.4%), increased SGPT (1.7%) and increased creatinine (0.7%). (At the time of approval.)
Clinically Significant Adverse Reactions (Rarely: <0.1%): Angioedema, manifested as swelling of the face, tongue, glottis and larynx accompanied by dyspnea, may occur rarely. If any of these signs are observed, Tanatril should be discontinued immediately and appropriate measures eg, administration of antihistaminic agents, adrenal cortex hormone agents, etc, and maintaining the airway should be taken.
Serious thrombocytopenia may occur rarely. If symptoms are observed, Tanatril should be discontinued immediately and appropriate measures taken.
Since acute renal failure (incidence <0.1%) and exacerbation of renal impairment may occur, the patient's clinical condition should be closely monitored by performing renal function tests. If any abnormalities are observed, appropriate measures eg, discontinuing administration, should be taken.
Clinically Significant Adverse Reactions (similar drugs): It has been reported that pancytopenia may occur with the use of other ACE inhibitors. If symptoms are observed, Tanatril should be discontinued immediately and appropriate measures taken.
It has been reported that pancreatitis may occur with the use of other ACE inhibitors. If an increase in blood concentration of amylase, lipase, etc, is observed, appropriate measures eg, discontinuing administration, should be taken.
Other Adverse Reactions: If any adverse reactions are observed, appropriate measures eg, discontinuing administration, should be taken. (See Table 1.)

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